Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures
Medical Device Expert News
Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
New ANVISA public consultations related to quality and safety of health services. Novas consultas públicas da ANVISA relacionadas à qualidade e segurança de serviços em…
Final rule will be at this link: FDA Issues Final Rule on Medical Device Classification Procedures A regra final será publicada neste link: FDA Issues Final Rule…
Some words from the US FDA about the duodenoscope problem, based on the post-market data : Statement from Jeff Shuren, M.D., J.D., Director of the Center…
Another hot topic, together with Cybersecurity, is SaMD (Software as a Medical Device). Updated information from TGA here – Regulation of Software as a Medical Device.…
Continuing with the duodenoscope topic: Olympus Medical pleads guilty to failing to file events notice: Justice Department. Continuando com o tema do duodenoscópios: Olympus Medical pleads…
MHRA – Field safety notices – 03 to 07 December 2018. As a reminder, as part of Post Market Surveillance (PMS), manufacturers should track field…
List of November 2018 510(k) clearances. With the recent suggestions by FDA management on future changes of the 510(k) process, keeping up-to-date with clearances (and potentially…
This goes back to the ongoing duodenoscopes problems related to design and reprocessing… Isso remonta aos problemas relacionados ao design e reprocessamento de duodenoscópios…. The…